Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome

March 6, 2014 updated by: Laboratoires Nutrition et Cardiometabolisme

A Randomized Double-blind Placebo Controlled Trial on the Effect of Stablor™ on the Abdominal Visceral Fat Mass Loss in Patients With a Metabolic Syndrome

The purpose of the study is to evaluate the impact of the intake of a dietary supplement STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Laval, Quebec, Canada
        • Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
  • France
      • Paris, France
        • Institut CardioMetabolisme et Nutrition (ICAN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • With a Body Mass Index (BMI) more than or equal to 25 kg/m² and less than 40 kg/m²,

  • With a metabolic syndrome characterized by a a waist circumference of more than 94 cm for the males (90 cm for South-Asians, Chinese and Japanese) and more than 80 cm for the females, and at least 2 of the following criteria :

    • Arterial Blood pressure > or = 130 mmHg (systolic) and/or more than or equal to 85 mmHg (diastolic) or stabilized with treatment for at least 6 months,
    • Fasting glycemia > or = 1 g/L or 5.6 mmol/L or stabilized with treatment for at least 6 months and non-diabetic < 1.26 g/L,
    • Triglycerides > or = 1.5 g/L or 1.71 mmol/L or stabilized with treatment for at least 6 months,
    • HDL Cholesterol <0.40 g/L or 1.03 mmol/L (males) and <0,5 g/l or 1.29 mmol/L (females) or stabilized with treatment for at least 6 months.

Exclusion Criteria:

  • Pregnant (positive pregnancy test at the selection visit or breast-feeding woman,
  • Woman of childbearing potential without an efficient contraception method,

The above information is not intended to contain all considerations relevant to a patient's potential participation in the clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stablor
dietary supplement Stablor
Dietary supplement: Stablor
Placebo Comparator: Placebo
dietary supplement Placebo
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in visceral fat area assessed by computerized tomodensitometry
Time Frame: From baseline to Week 12
From baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers
Time Frame: from baseline to end of study
from baseline to end of study
Quality of life, psychological and behavioral changes
Time Frame: From baseline to end of study
From baseline to end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Nutrition et Cardiometabolisme

Investigators

  • Principal Investigator: Karine Clement, MD, Institut CardioMetabolisme et Nutrition (ICAN)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCM-EFF-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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